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Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

NCT05885763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-14

Study results available
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Summary

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.

Conditions

  • End Stage Renal Disease on Hemodialysis

Interventions

DRUG

Difelikefalin Injection

Participants receive Difelikefalin three times a week (0,5 micrograms/kg dry body weight). Difelikefalin is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • Vifor Fresenius Medical Care Renal Pharma

    lead INDUSTRY

Principal Investigators

  • Milica Enoiu, PhD · Vifor Pharma Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2023-10-09
Completion
2023-10-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885763 on ClinicalTrials.gov